Sample collection device and method

ABSTRACT

The invention is directed to sample collection assemblies and methods for collecting a sample from a collection source.

PRIORITY DATA

This application is a continuation of U.S. application Ser. No.11/035,662, filed Jan. 14, 2005, which claimed priority from U.S.Provisional Application Ser. No. 60/537,057, which is incorporatedherein by reference

BACKGROUND

Devices and systems are available for collection of biological samplesfor analysis by known methods including immunochemistry, PCR,biochemical analysis, microbial culture, mass spectrometry, andbiosensor-based detection. However, often times a particular samplecollection device may be difficult to use for collecting a particulartype of sample or from a particular source or for a particular type ofanalysis. The present invention is directed to novel sample collectiondevices, assemblies and methods particularly suited for collection,storage and/or analysis of a biological sample, such as fecal material,from a human or animal.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plane view of an embodiment of a sample collection assemblyaccording to the invention.

FIG. 2 is a plane view of an alternative embodiment of a samplecollection assembly according to the invention.

FIG. 3 is a cross sectional view through line 3-3 of a scoop accordingto the invention.

FIG. 4 is a perspective view of the working end of a collection wandaccording to the invention.

FIG. 5 is a perspective view of an assay chamber with a partition memberaccording to the invention.

FIG. 6 is a perspective view of an embodiment of an assay chamber andcap according to the invention.

FIG. 7 is a perspective view of an embodiment of an assay chamberaccording to the invention.

FIG. 8 is a perspective view of a portion of a collection wand accordingto the invention.

FIGS. 9A-9B illustrate an embodiment of a protocol for testing fecalsamples in association with the sample collection assembly.

FIG. 10 illustrates another embodiment of a protocol for testing fecalsamples in association with the sample collection assembly.

DETAILED DESCRIPTION

The present invention is directed to a sample collection assemblycomprising a collection tube and collection wand. The collection tubehas a barrel portion, an assay chamber and a partition member. Thecollection wand includes an operating end and a working end and isconfigured to fit within the collection tube. The operating end of thecollection wand includes a handle configured for gripping and/ororientation by the operator's hand. The working end includes acollection tip suitable for collecting a measured amount of sample. Ashaft can extend between the operating end and the collection tip. Theshaft can be of any length appropriate for collection of the sample froma particular source. In some embodiments, the shaft can be scored orotherwise weakened to provide for separation of a portion of the shaftfrom the collection tip after sample collection. In some, embodiments,the shaft may have a mark or marks indicating depth of insertion forsample collection.

For descriptive purposes herein, one embodiment of a sample collectionassembly of the invention will be described with reference to thefigures. The illustrated embodiments may be particularly suited forcollecting a fecal sample from the rectum of a horse or a productionanimal such as a cow, sheep or, pig or a companion animal such as a dogor a cat, or a human. Thus, according to this embodiment, the collectiontip at the working end can be passed through the anus of a cow or otherspecies and directed towards a part of the rectal wall such as thedorsal wall. Once at a desired location the handle at the operating endcan be rotated to cause the collection tip to collect a fecal samplealong the rectal wall, such as along the dorsal lateral wall, as thecollection wand is rotated about its longitudinal axis.

In the drawings, like reference numerals represent like parts andassemblies throughout the several views. Reference to the drawings isnot intended to limit the scope of the invention.

Referring to FIG. 1, a sample collection assembly 10 includes acollection tube 11 and a collection wand 12. Collection tube 11 includesa proximal end 13 having an opening 14 and a distal end 15. Collectiontube 11 also includes a barrel portion 16 and assay chamber 17. In someembodiments, collection tube 11 can be scored or otherwise weakened atlocation 18 to provide for selective detachment of barrel portion 16from assay chamber 17. A partition member 19 can be located near theproximal end of the assay chamber and is sealingly attached or integralwith the inner perimeter of collection tube 11. If a weakened location18 is present, partition member 19 can be located either proximal ordistal thereto. The partition member 19 includes an orifice 20 forpassage of the wand as will be further described below. The collectiontube 11 can be manufactured from any suitable material including apolymeric material, such as plastics commonly used in the art forsimilar sample material collection and/or performance of analyses aswill be apparent from reading the present disclosure. Examples ofsuitable plastics include polyurethane, polysterene, polyvinyl,polypropylene, polyurethane, etc. Parts of the collection tube, such asa detachable barrel, may also be made of biodegradable or organicmaterial such as card board. The sample collection assembly 10 isamenable to sterilization during or after manufacture either as anassembled unit or as separate components.

The orifice 20 of partition member 19 can be covered with a polymericsheet or foil that preferably seals the assay chamber 17 prior to usebut can be penetrated by the collection wand 12. Suitable materials forcovering the orifice 20 include, for example, polymers such as poly(acrylonitrile-co-butadiene-co-styrene) polymers, acrylic polymers suchas the polymethylmethacrylate, poly-n-butyl acrylate,poly(ethylene-co-acrylic acid), poly(ethylene-co-methacrylate), etc.;fluoropolymers including polytetrafluoroethylene (teflon),poly(ethylene-co-tetrafluoroethylene) copolymers,(tetrafluoroethylene-co- propylene) copolymers, polyvinyl fluoridepolymers, etc., polyamides such as nylon 6, nylon 6,6, etc.;polycarbonates; polyesters such as poly(ethylene-co-terephthalate),poly(ethylene-co-1,4-naphthalene dicarboxylate),poly(butylene-co-terephthalate); polyimide materials; polyethylenematerials including low density polyethylene; linear low densitypolyethylene, high density polyethylene, high molecular weight highdensity polyethylene, etc.; polypropylene, biaxially orientedpolypropylene; polystyrene, biaxially oriented polystyrene; vinyl filmsincluding polyvinyl chloride. (vinyl chloride-co-vinyl acetate)copolymers, polyvinylidene chloride. polyvinyl alcohol, (vinylchloride-co-vinylidene dichloride) copolymers, specialty films includingpolysulfone, polyphenylene sulfide, polyphenylene oxide, liquid crystalpolyesters, polyether ketones, polyvinylbutyrl, foils; self-sealingmembranes; etc. Thus, when sealed the assay chamber can be preloadedwith a reagent, e.g., gas, liquid or solid material, that may be used toprepare or preserve the sample for downstream analysis. Examples ofmaterials include glass fragmentation beads (as the same are known andunderstood by one of ordinary skill in the art, washing solutions,stabilizers, buffers, enzymes, etc. Embodiments of the invention,however, are not limited to these examples. One of ordinary skill in theart will appreciate other materials which may be suited for use inpreparing and/or preserving the sample for downstream analysis. In someembodiments, multiple partition members may be present in the collectionassembly. Some of the partition members may include the sealing materialwhile other members may include the orifice.

In different embodiments the assay chamber 17 can serve as a containerfor collection and transportation of samples as well as for performanceof part or all of the analysis. The assay chamber 17 can be configuredfor removal of the collected sample at the laboratory at the time ofanalysis. Alternatively, the assay chamber 17 can be sized andconfigured to fit within a tray or other holder that is compatible withautomated sample analyzers and other laboratory equipment such ascentrifuges, shakers, etc. and some or all of the analysis process stepsperformed directly in the chamber 17. For example, the assay chamber 17can be sized for insertion into a multi-well (e.g., 96 well) analysistray and the sample processed and analyzed directly in assay chamber 17.In some embodiments, the assay chamber 17 may also fit individually withstandard laboratory equipment such as centrifuges, shakers, etc.

Collection wand 12 includes an operating end 25 at proximal end 26 andworking end 27 at distal end 28. Operating end 25 can include a handle30 configured to fit and/or orient with the operator's hand. A shaft 31between operating end 25 and working end 27 can be of any lengthsufficient to reach the sample source. For example, if the sample sourceis the rectum of a cow, the shaft can be about 10_cm to 25_cm, in someembodiments, about 15 cm.

Working end 27 can include a scoop 33 for collecting a sample. The shapeand volume of scoop 33 can be sized, designed, and/or configured tocollect a predetermined sample volume as suited for a particularanalytical test. Shaft 31 may contain a plug (e.g., plug 60 asillustrated in FIG. 2) that sealingly fits orifice 20 of a partitionmember 19. Shaft 31 can be scored or otherwise weakened at location 35to allow for selective detachment of the scoop 33 from shaft 31. Theamount of force necessary for detachment of scoop 33 from shaft 31 ispreferably selected to provide for ease of detachment when desired, yetnot so easy that the scoop 33 inadvertently detaches during samplecollection. As one of ordinary skill in the art will appreciate fromreading this disclosure, various embodiments can include multipledividers, some of which can be used for separating and sealing and/orproviding additional seals for a sample to be tested. Likewise, as onewill appreciate upon reading this disclosure, in the various embodimentsdividers are included which function in a leveling role.

FIG. 3, is a cross sectional view through line 3-3 of scoop 33 in FIGS.1 and 4. In preferred embodiments, the cross sectional shape of scoop is33 is configured to have a complementary fit with the shape of orifice20 of partition member 19 as shown in FIG. 5. The complementary fit ofscoop 33 with orifice 20 provides for removal of excess sample materialfrom the exterior surface of scoop 33. This ensures that a consistentsample size of an amount predetermined by the scoop 33 volume isdelivered to the assay chamber 17.

The handle 30, shaft 31 and scoop 33 can all be manufactured from thesame material. Alternatively, some or all the these components can bemanufactured from different materials that are presently or later knownin the art for collecting and handling samples of similar biologicalmaterials. Suitable materials for the scoop include plastics and metals.The handle and shaft can also be manufactured from plastics, metals,wood, etc. In various embodiments the scoop is manufactured from amaterial that facilitates removal of a sample from the scoop surface,for example, polyurethane, PTFE, high density polyethylene (HDPE),Teflon, etc.

Referring to FIG. 2, the handle 30 can have a distal end 5 configured tosealing fit within opening 14 at the proximal end 13 of collection tube11. Alternatively, as shown in FIG. 1, a cap 36 can be located at thedistal end 5 of handle 30 and include internal threads (not visible) formating with external threads 37 if present at the proximal end of 13 ofcollection tube 11 or proximal end of assay tube 17. Alternatively, aseparate cap 50 (shown in FIG. 6) may be used for sealing of thecollection tube or the proximal end of the assay tube 17.

In use, collection wand 12 is removed from collection tube 11 and passedinto the collection source, such as the rectum of an animal. The handle30 can be rotated to facilitate collection of a fecal sample into scoop33 as described above. After removal from the animal, the distal end 28of wand 12 is passed through opening 14 of collection tube 11. The scoop33 is then penetrated through orifice 20 and sealing material of one ormore partition members 19 and into the assay chamber 17. After the scoop33 passes through orifice 20, excess sample material over thepredetermined scoop volume remains outside of the assay chamber.

In some embodiments the wand 12 can be inserted into the collection tube11 with the assay chamber 17 removed. As the reader will appreciate,this will allow for the scoop to be advanced and retracted within thenow open ended barrel 16 of the collection tube 11. In such embodiments,the barrel 16 will serve as a shield and/or sheath while passed into thecollection source, such as the rectum of an animal. That is, in someembodiments collection wand 12 may be passed into the collection sourcewhilst protected inside barrel 16 and the working end 27 of collectionwand 12 exposed once at the site of sample collection. After a sample iscollected with the tip of the working end 27 designed to collect aspecific amount of sample, e.g., scoop 33, the working end 27 can beretracted into the barrel 16 and the assembly retracted from thecollection source. The scoop could then be penetrated through orifice 20and sealing material of one or more partition members 19 and into theassay chamber 17, as described above.

Referring to FIG. 2, if handle 30 has a distal end 5 configured to sealopening 14 the sample may be shipped to the lab sealed within collectiontube 11. Alternatively, as shown in FIG. 1, if handle 30 includes athreaded cap 36, cap 36 can be threaded onto threads 37 on the exteriorof collection tube 11 to seal the sample within collection tube 11.

In other alternatives, some or all portions of the barrel 16 ofcollection tube 11 and some or all of shaft 31 of collection wand 12 canbe removed and disposed. The sample can then be sealed in assay chamber17. Referring to FIGS. 1, 3 and 4-6, in one embodiment collection tube11 is divided at weakened location 18 leaving assay chamber 17 in aconfiguration such as shown in FIG. 5 or 6. As described above, apartition member 19 can be located distal to weakened location 18 andremain in assay chamber 17 (FIG. 5.) Alternatively, a partition member19 can be located proximal to weakened area 18, and thus will not bepresent in assay chamber 17 (FIG. 6). In the embodiment of either FIG. 5or 6, a cap 50 can be used to seal assay chamber 17. Cap 50 can beattached by sealing to assay chamber 17 by any suitable means, includingfor example internal threads (not seen) that can mate with threads 51 onthe exterior of chamber 17. The scoop 33 of collection wand 12 can beseparated at weakened location 35 to fit into chamber 17.

Referring now to FIGS. 2, 7 and 8, in an alternative embodiment,collection wand 12 can include a seal plug 60 located distal to weakenedlocation 35. According to this embodiment, partition member 19 ofcollection tube 11 is located distal to weakened region 18 such thatafter separation of barrel portion 16 from assay chamber 17, partitionmember 19 remains in assay chamber 17 and seal plug 60 can be force fitinto orifice 20 of partition member 19 to seal assay chamber 17. Afterremoving shaft 31 at weakened location 35, a cap 50 can be used tofurther seal chamber 17.

As shown in FIG. 6 the assay chamber can include a label 70 such as abar code label, radio frequency label, or other suitable label foridentifying and tracking a sample.

A sample collection device according to the invention can be used forcollecting samples that can be analyzed using, for example, PCRanalysis, other methods of nucleic acid-based diagnostics,immunochemistry, biochemical analysis, microbial culture, massspectrometry, and biosensor-based detection etc. Embodiments of theinvention, however, are not limited to these examples. One of ordinaryskill in the art will appreciate other types of analyses which may beperformed on samples collected by the sample collection device disclosedherein.

As one example, the sample collection devices herein can beadvantageously used to detect bacterial organisms shed in the feces suchas Mycobacterium paratuberculosis. The following process for detectingthis organism is not meant to limit the invention, but rather to providean example of use.

FIGS. 9A-9B illustrate an embodiment of a protocol for testing fecalsamples in association with the sample collection assembly. FIGS. 9A-9B,illustrate an embodiment for a 96 sample preparation. As shown in FIG.9A, at 904, two samples, each containing two grams or other suitableamount of fecal material, can be collected using the collection wands oftwo sample collection devices and individually transferred into assaychambers containing one milliliter or other suitable volume of anaqueous solution, such as a buffer or laboratory water. Next, the twosamples can be shaken, for example, shaken for thirty minutes. As shownat 906, each of the two samples can be further divided into three testtubes containing additional solutions. In each of the resulting samplesten five millimeter beads can be added and the samples can be subjectedto a bead beater, e.g., for five minutes. The sample can further beplaced in a centrifuge for five minutes at 1000×g at four degreesCelsius. 1.4 milliliters of supernatant from each tube can betransferred into corresponding fresh tubes containing 0.6 millilitersASL buffer and 250 milligrams of 0.1 millimeter beads (as shown at 908).The samples can be incubated at 70 degrees Celsius for thirty minutesand placed, once again, in a bead beater, e.g., for another fiveminutes, and once again be placed in a centrifuge for five minutes at1000×g at four degrees Celsius. As shown at 912, samples can be furtherprocessed in a QIAamp 96 DNA Blood BioRobot kit such as in a BioRobot9604. For example, tubes containing the samples can be placed eight to abar and a number of bars may be batch processed at one time. At 914 asuitable mechanism can be employed for identifying and tracking thesamples, e.g., scanning bar codes. As shown at 916, 400 micro liters ofsupernatant from the samples can be transferred from each of tube andarranged as twelve bars of eight to the corresponding wells of a 96-wellblock and further undergo Aliquoting of QIAGEN protease, e.g., 40 microliters per well, and 400 micro liters of a lysis buffer, e.g., AL, canbe added. Further, the samples can undergo incubation at 70 degreesCelsius for thirty minutes in a thermoblock.

In FIG. 9B at 920 400 micro liters of ethanol can be added and thesamples transferred. A first overlay of 650 micro liters of lysate toQIAamp 96 plate is performed and the samples subjected to a vacuum forthree minutes. The remaining lysate can be transferred with 310 microliters of Buffer AW1. The samples can be subjected to a vacuum foranother seven minutes. At 922, the samples can undergo a first wash with310 micro liters of Buffer AW1. The samples can be subjected to a vacuumfor another five minutes. At 924, the samples can undergo a second washwith 1000 micro liters of Buffer AW2. The samples can be subjected to avacuum for another two minutes. At 926, the samples can undergo a thirdwash with 1,100 micro liters of Buffer AW2. The samples can be subjectedto a vacuum for another two minutes. The samples can be placed in acentrifuge for ten minutes at 5,700×g to dry. At 928, 100 micro litersof dH₂O can be added to the samples and the samples can be incubatedfifteen minutes with shaking at room temperature. The samples can beplaced in a centrifuge for three minutes at 5,700×g to elute. Accordingto this exemplary embodiment, the samples are then ready to use as DNAsamples as shown at 930.

FIG. 10 illustrates another embodiment of a protocol for testing fecalsamples in association with the sample collection assembly. FIG. 10illustrates an embodiment for a single sample preparation. As shown inFIG. 10, this exemplary testing protocol embodiment in association withthe sample collection assembly includes collection of two samples, eachcontaining two grams of fecal material, using the collection wands oftwo sample collection devices and individually transferring the samplesinto assay chambers containing one milliliter of an aqueous solution.After transportation to the laboratory, as shown at 1004, water of abuffer containing salts and/or enzymes to dilute to a specified amount,e.g., 2 fold, etc., can be added. The two samples can be agitated to mixthoroughly for a given period of time, e.g., thirty minutes. Stage 1006illustrates continuing to process the sample or aliquot material, e.g.,into three replicate tubes. A specified number, e.g., ten, beads ofsilica, zirconium, or a combination of glass and or metal having aspecified diameter, e.g., five millimeters, can be added. The samplescan be agitated using a manual or robotic device, e.g., bead beater ormixer mill, for a specified period of time, e.g., five minutes. Thesample can further be placed in a centrifuge for a specified period oftime, temperature and relative centrifugal force, e.g., 1000×g at fourdegrees Celsius for five minutes. At 1008 a given amount of supernatant,e.g., 1.4 milliliters, can be added to a specified volume, e.g., 0.6milliliters of a solubalization buffer, e.g., ASL. Further 250milligrams of 0.1 millimeter beads, e.g., silica or zirconium can beadded. At 1010 the samples can once again be agitated with a beadbeater, e.g., for another five minutes and incubated at 70 degreesCelsius for thirty minutes. The sample can once again be placed in acentrifuge for five minutes at 1000×g at four degrees Celsius. At 1012,one can prepare DNA using methods that are familiar to one of ordinaryskill in the art or using a specified kit, e.g., Qiagen blood kit. 200micro liters of supernatant along with 20 micron liters of PK and 200micro liters of a buffer, e.g., AL, can be added. Further, the samplecan undergo incubation at 70 degrees Celsius for thirty minutes. Asshown at 1014 a washing step may be performed using Ethanol and buffersAW1, AW2, etc. The sample can again undergo a centrifuge for threeminutes at 6000×g. According to this exemplary embodiment, the sample isthen ready to use for DNA sampling as shown at 1016.

In other embodiments, the protocols may be simplified, e.g., steps maybe omitted, centrifugation used instead of vacuum, and other volumes,buffers, or g forces used. Different portions of the protocol may alsobe performed at different sites with some steps being accomplished atthe collection location, e.g., an animal production facility such as adairy farm, some steps being accomplished during transportation, andothers at a facility such as a laboratory where the sample has beentransported to.

Although specific embodiments have been illustrated and describedherein, those of ordinary skill in the art will appreciate that anyarrangement calculated to achieve the same techniques can be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of the embodiments of theinvention. It is to be understood that the above description has beenmade in an illustrative fashion, and not a restrictive one. Combinationof the above embodiments, and other embodiments not specificallydescribed herein will be apparent to those of skill in the art uponreviewing the above description. The scope of the various embodiments ofthe invention includes any other applications in which the abovestructures and methods are used. Therefore, the scope of variousembodiments of the invention should be determined with reference to theappended claims, along with the full range of equivalents to which suchclaims are entitled.

In the foregoing Detailed Description, various features are groupedtogether in a single embodiment for the purpose of streamlining thedisclosure. This method of disclosure is not to be interpreted asreflecting an intention that the embodiments of the invention requiremore features than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter lies in less than allfeatures of a single disclosed embodiment. Thus, the following claimsare hereby incorporated into the Detailed Description, with each claimstanding on its own as a separate embodiment.

1. A sample collection assembly comprising: a collection device having a working end, and an operating end; and a container to receive the collection device, having an assay chamber and a partition member; wherein the working end of the collection device has a collection tip configured for collecting a sample; wherein a shaft extends between the working end and the operating end; and wherein the assay chamber is detachable such that detaching the assay chamber from the container causes the shaft to detach with the collection tip therein.
 2. The sample collection assembly of claim 1 wherein the shaft includes a weakened location between the working end and the operating end at which weakened location the shaft detaches when the assay chamber is detached.
 3. The sample collection assembly of claim 1 wherein the shaft includes a sealing arrangement distal from a location of shaft detachment and proximal to the partition member for sealing the assay chamber.
 4. The sample collection assembly of claim 3 wherein the container is detachable from the assay chamber and the sealing arrangement comprises a plug configured to seal the orifice of the partition member.
 5. The sample collection assembly of claim 1 wherein the partition member includes an orifice configured for snug passage of the working end therethrough.
 6. The sample collection assembly of claim 5 wherein the partition member is configured for collection of a measured amount of a sample.
 7. The sample collection assembly of claim 1 wherein the collection tip is configured to collect a measured amount of a sample.
 8. The sample collection assembly of claim 1 wherein the collection device includes the collection tip being configured as a scoop for collecting a predetermined volume of sample.
 9. The sample collection assembly of claim 1 wherein the partition member includes an orifice with a boundary complementary to a cross-section of the collection tip such that an excess of a sample material is excluded from entering the assay chamber when passing the collection tip through the orifice.
 10. The sample collection assembly of claim 1 wherein the assay chamber is adapted for transportation, processing, and analysis of a sample.
 11. The sample collection assembly of claim 10 wherein the assay chamber is adapted to be pre-sealed with a reagent therein as useful to transportation, processing, and analysis of the sample.
 12. The sample collection assembly of claim 10 wherein the assay chamber is adapted to be detached and interfaced with other standard laboratory equipment individually or in multi-well formats.
 13. The sample collection assembly of claim 1 wherein the working end is adapted to be inserted in body cavities of biological entities including humans and animals for collection of biological samples.
 14. The sample collection assembly of claim 13 wherein the working end is adapted to be inserted through an anus for collection of feces and samples from regions of a gastro-intestinal tract.
 15. The sample collection assembly of claim 1 wherein the working end and the assay chamber are adapted to collect, transport, and assay infectious agents.
 16. The sample collection assembly of claim 15 wherein the infectious agents include infectious agents present in host species including humans and animals.
 17. The sample collection assembly of claim 16 wherein the working end and the assay chamber are adapted to collect, transport, and analyze sample for detection and diagnosis of Mycobacterium avium subspecies paratuberculosis.
 18. The sample collection assembly of claim 15 wherein the working end and the assay chamber are adapted to collect, transport, and analyze samples with application in biodefense.
 19. A sterile sample collection assembly, comprising: an apparatus configured to collect a measured amount of a sample and to process the sample for analysis; including: a collection device having a working end, and an operating end; and a container to receive the collection device, having an assay chamber and a partition member; wherein the working end of the collection device has a collection tip configured for collecting a sample; wherein a shaft extends between the working end and the operating end; and wherein the assay chamber is detachable such that detaching the assay chamber from the container causes the shaft to detach with the collection tip therein.
 20. A sample collection assembly, comprising: an apparatus configured to collect, transport, and assay samples for diagnosis of Mycobacterium avium subspecies paratuberculosis, including: a collection device having a working end, and an operating end; and a container to receive the collection device, having an assay chamber and a partition member; wherein the working end of the collection device has a collection tip configured for collecting a sample; wherein a shaft extends between the working end and the operating end; and wherein the assay chamber is detachable such that detaching the assay chamber from the container causes the shaft to detach with the collection tip therein. 